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Completed

NCT Number: NCT02216188

Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.

In addition, up to 8 patients will be offered participation within an untreated control group.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

Vienna, State of Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior participation in AFF008 and AFF008E
  • Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory)
  • In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these
  • Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
  • Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator

Exclusion criteria

  • Women of childbearing potential without birth control or pregnant women
  • Participation in another clinical trial (except AFF008E) within 3 months before Visit 0
  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
  • Autoimmune disease or allergy to components of the vaccine
  • History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
  • Active infectious disease
  • Immunodeficiency
  • Significant systemic illness or psychiatric illness
  • Alcoholism or substance abuse
  • Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep brain stimulation
  • Venous status rendering it impossible to place an i.v. access

Treatment and study plan

AFFITOPE® PD01A

Biological

s.c. injection

Control

Other

Untreated control group

Primary outcomes

  1. Tolerability

    Time frame: 6 month

    • Occurrence of any Adverse Events (AE)
    • Occurrence of any Serious Adverse Events (SAE)
    • Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)

Secondary outcomes

  1. Immunological

    Time frame: 6 month

    • Titer of antibodies specific for the immunizing peptide, KLH (keyhole limpet hemocyanin; carrier protein), aSynuclein (aSyn), bSyn, aggregated aSyn as assessed by ELlSA, FACS (or equivalent methods)

Other outcomes

  1. Clinical Activity

    Time frame: 6 month

    • Change in motor symptoms (MDS-UPDRS III)
    • Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, PD NMS, cognition)
    • Change in biological and radiological markers (e.g. CSF alpha synuclein Levels in cerebrospinal fluid)

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study title

Phase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008

Acronym: AFF008A

Important dates

Study start
2014
Primary completion
2015
First posted
Aug 13, 2014
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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